Unit of competency Outline

Date retreived
23/07/2026 11:12 PM AWST

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Facilitate contamination control

Facilitate contamination control

Unit of competency
National Code
FBPPHM4003
State Code
OAN17
TGA Status
Current
DTWD Status
Approved
Current Release Number
2.00
Current Release Date
21/01/2021
View on TGA
State Implementation and Classification
Approved Date
18/04/2019
Field of Education
030717 - Plant And Machine Operations
Original Release Date
18/04/2019
Nominal Hours
40
Description
This unit of competency describes the skills and knowledge required to identify and implement contamination control measures in a pharmaceutical manufacturing facility.The unit applies to individuals with specialised skills and knowledge of Good Manufacturing Practice (GMP) requirements who are responsible for overseeing the implementation of contamination control programs within pharmaceutical manufacturing operations and have responsibility for the output of others. This includes applying and communicating non-routine technical solutions to predictable and unpredictable problems.No licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Review contamination risks and related control measures to meet GMP requirements
  • 1.1 Identify hazards that could present contamination risks by type, origin and product association
  • 1.2 Review hazards and risk control measures to confirm they meet GMP requirements
  • 1.3 Conduct risk assessment according to GMP requirements and workplace procedures
  • 1.4 Confirm control measures
2. Implement procedures used to control risk of cross contamination
  • 2.1 Identify effective barriers and control systems to minimise risk of contamination according to GMP requirements and workplace procedures
  • 2.2 Conduct in-process and environmental monitoring according to GMP requirements and workplace procedures
  • 2.3 Validate cleaning processes according to workplace procedures
  • 2.4 Confirm line clearance procedures
  • 2.5 Ensure personal hygiene and conduct of personnel in work area meets GMP requirements
  • 2.6 Ensure operators have the skills and knowledge required to apply contamination control measures
No information
No information
Replaces
State Code National Code Title Type
D4693 FDFPH4003A Facilitate contamination control Unit of competency